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1 What Imigran Radis is and what it is used for

Each Imigran Radis tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT₁ receptor agonists).

Imigran Radis is used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Imigran Radis is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.

2 Before you use Imigran Radis

Don't use Imigran Radis:

•    If you’re allergic (hypersensitive) to sumatriptan, or any of the other ingredients (listed in Section 6)

•    If you have a heart problem such as narrowing of the arteries (ischaemic heart disease) or chest pains (angina), or have already had a heart attack

•    If you have circulation problems in your legs that cause cramp-like pains when you walk (peripheral vascular disease)

•    If you have had a stroke or a ministroke (also called a transient ischaemic attack or TIA)

•    If you have high blood pressure.

You may be able to use Imigran if your high blood pressure is mild and is being treated

•    If you have serious liver disease

•    With other migraine medicines,

including those which contain ergotamine, or similar medicines such as methysergide maleate; or any triptan or 5HTi agonist (such as naratriptan or zolmitriptan)

•    With any of the following antidepressants

•    MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in the last 2 weeks

•    SSRIs (selective serotonin reuptake inhibitors) including citalopram, fluoxetine, fluvoxamine, paroxetine and sertaline

•    SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine and duloxetine

•    For children under 18 years of age.

If any of these apply to you:

^ Tell your doctor, and don’t use

Imigran Radis.

Take special care with Imigran

Radis

Your doctor needs to know certain

information before you use Imigran:

If you have any extra risk factors

•    If you are a heavy smoker or are using nicotine replacement therapy,

and especially

•    If you are a man aged over 40, or

•    If you are a woman who has been through the menopause.

In very rare cases, people have developed serious heart conditions after using Imigran, even though they had no signs of heart disease before. If any of the points above applies to you it could mean you have a greater risk of developing heart disease - so:

^Tell your doctor so that your heart function can be checked before Imigran is prescribed for you.

If you have a history of fits (seizures) Or if you have other conditions which might make it more likely that you'll have a fit - for example, a head injury or alcoholism:

If you have liver or kidney disease

If either of these apply to you:

^Tell your doctor so that you can be supervised more closely.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Imigran. If you know you are allergic to an antibiotic but you are not sure whether it is a sulphonamide:

^Tell your doctor or pharmacist before using Imigran.

If you are taking anti- depressants called SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)

^ Tell your doctor or pharmacist before using Imigran. Also see Other medicines and Imigran, below.

If you use Imigran frequently

Using Imigran too often may make your headaches worse.

^ Tell your doctor if this applies to you. He or she may recommend you stop using Imigran.

If you feel pain or tightness in your chest after you use Imigran

These effects may be intense but they usually pass quickly. If they don't pass quickly, or they become severe:

^ Get medical help immediately.

Section 4 (overleaf) has more information about these possible side effects.

Other medicines and Imigran

Tell your doctor if you’re taking any other medicines or have recently taken any. This includes any herbal products, dietary supplements such as vitamins, iron or calcium or medicines you've bought without a prescription.

Some medicines must not be taken with Imigran and others may cause adverse effects if they're taken with Imigran. You must tell your doctor if you are taking:

•    ergotamine also used to treat migraine, or similar medicines such as methysergide maleate; or any triptan or 5HT1 agonist (such as naratriptan or zolmitriptan). Don't use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Don't take them again for at least 6 hours after using Imigran

•    MAOIs used to treat depression. Don't use Imigran if you have taken these in the last 2 weeks

•    SSRIs and SNRIs used to treat depression. Using Imigran with these medicines can cause serotonin syndrome (a collection of symptoms which can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heartbeat and shaking). Tell your doctor immediately if you are affected in this way.

•    St John’s Wort (Hypericum perforatum). Taking herbal remedies containing St John's Wort together with Imigran may make side effects more likely.

Pregnancy and breast-feeding

•    If you are pregnant or could be pregnant, talk to your doctor before you use Imigran. There is only limited information about the safety of Imigran for pregnant women, though up till now there is no evidence of any increased risk of birth defects.

Your doctor will discuss with you whether or not you should use Imigran while you are pregnant

•    Don’t breast-feed your baby for 12 hours after using Imigran. If you express any breast milk during this time, discard the milk and don't give it to your baby.

Driving and using machines

Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, don’t drive or operate machinery.

3 How to use Imigran Radis

Always take Imigran Radis exactly as

your doctor has told you. Check with

your doctor or pharmacist if you are not

sure.

When to take Imigran Radis

•    It's best to take Imigran Radis as soon as you feel a migraine coming on, although you can take it at any time during an attack

•    Don't use Imigran Radis to try to prevent an attack - only use it after your migraine symptoms start.

How much to take

Adults aged 18 to 65

•    The usual dose for adults aged 18

to 65 is one Imigran Radis 50mg tablet, swallowed whole with water (do not crush or chew it). Some patients may need a 100mg dose - you should follow your doctor's advice

•    If you have problems swallowing tablets, you can disperse a tablet in a small amount of water before you take it - although this may have a bitter taste.

Children under 18

•    Imigran Radis is not recommended for children under 18 years old.

Older people (aged over 65)

•    Imigran Radis is not recommended for people aged over 65.

If your symptoms start to come back

•    You can take a second Imigran Radis tablet if at least 2 hours have passed since the first tablet. Don't take more than 300 mg in total in 24 hours.

If the first tablet has no effect

•    Don't take a second tablet or any

other Imigran preparation for the same attack. Imigran can still be used for your next attack.

If Imigran Radis doesn't give you any relief.

^ Ask your doctor or pharmacist for advice.

If you take more Imigran than you should

•    Don't take more than six 50 mg tablets or three 100 mg tablets

(that's 300mg in total) in 24 hours.

Taking too much Imigran Radis could make you ill. If you have taken more than 300mg in 24 hours:

^ Contact your doctor for advice.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Imigran Radis tablets can cause side effects, but not everybody gets them.

Allergic reaction: get doctor's help straight away

The following side effects have occurred but their exact frequency is not known.

•    The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after using Imigran:

^ Don't use any more. Contact a doctor straight away.

Common side effects

(affect up to 1 in 10 people)

•    Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but generally pass quickly.

If these effects continue or become severe (especially the chest pain):

^ Get medical help urgently. In a

very small number of people these symptoms can be caused by a heart attack.

Other common side effects include:

•    Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself

•    Tiredness or drowsiness

•    Dizziness, feeling weak, or getting hot flushes

•    Temporary increase in blood pressure.

•    Shortness of breath

•    Aching muscles.

Very rare side effects

(affect up to 1 in 10,000 people)

•    Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are taking Imigran Radis.

Some patients may have the following side effects but it is not known how often they occur

•    Seizures/fits, tremors, muscle spasm, neck stiffness

•    Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some cases even permanent defects (although these may be due to the migraine attack itself)

•    Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains (angina) or heart attack

•    Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud’s phenomenon)

•    Feeling faint (blood pressure may go down)

•    Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis)

•    Diarrhoea

•    Pain in the joints

•    Feeling anxious

•    Excessive sweating.

If you get side effects

If you notice any unwanted effects,

even ones not listed in this leaflet, or if any of the side effects becomes troublesome:

^ Tell your doctor or pharmacist.

5 How to store Imigran Radis

As with all medicines, KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 30°C.

If your doctor stops your treatment, do not keep any leftover tablets unless your doctor tells you to. Return any unused tablets to your pharmacist for safe disposal.

Do not use IMIGRAN RADIS tablets after the expiry date printed on the carton or foil but return them to your pharmacist.

If your tablets become discoloured or show any signs of deterioration consult your pharmacist, who will advise you what to do.

6 Further Information

What Imigran Radis contains

Each film-coated tablet contains 50mg of the active ingredient sumatriptan (as the succinate).

There are also other inactive ingredients in your medicine. These are calcium hydrogen phosphate anhydrous, microcrystalline cellulose, sodium hydrogen carbonate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), glycerol triacetate and red iron oxide (E172).

What Imigran Radis looks like and contents of the pack

The tablets are pink, film-coated, triangular-shaped, bi-convex tablets debossed 'GS 1YM' on one face and '50' on the other face. Imigran Radis is available in pack sizes of 6 tablets in blister strips.

Manufactured by: Glaxo Wellcome Farmaceutica, Lda. R. Dr. Antonio Loureiro Borges, 3 Arquiparque, Miraflores, 1495-131 Alges, Portugal.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Imigran Radis™ 50mg tablets

PL No: 18799/1436    POM

Leaflet date: 30.04.2012

Imigran and Radis are registered trademarks of GlaxoSmithKline